A study to assess the efficacy and safety of Diphtheria and Tetanus vaccine in Healthy participants aged 10 t0 60 years.
- Registration Number
- CTRI/2023/05/052325
- Lead Sponsor
- Panacea Biotec Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Healthy male & female subjects aged 10 to 60 years.
2. Subjects in good health, based on medical history and physical examination.
3. Subject/Parent/LAR willing to participate throughout the study period.
4. Subject/Parent/LAR is willing to provide written Informed Consent/Assent form.
5. Past history of primary immunization with diphtheria and tetanus.
6. Inclusion criteria for females:
6.1 Female with non-child bearing potential (Females having documented history of surgical sterilization or are postmenopausal (12 months of amenorrhea after the last menstrual period) or are pre-menarche girls)
6.2 Female with child bearing potential is eligible if:
• Subject has used an effective method of contraception or abstinence from at least 4 weeks prior to enrollment in the study
AND
• Subject is willing to avoid pregnancies throughout the study by use of an effective method of contraception or abstinence
AND
• Subject has negative urine pregnancy test on the day of vaccination
1. Breast feeding women
2. Subjects who have any clinically significant chronic disease, which, in the opinion of the investigator would endanger the volunteer’s /subject’s well-being or interfere with the evaluation of the study objectives.
3. Known impairment of the immune function, including, but not limited to: Diabetes Mellitus, Cancer, Autoimmune diseases, Asthma, Asplenia etc. 4. Known history of HIV, hepatitis B, and hepatitis C reported by the subject.
5. History of any Bleeding Disorder.
6. History of severe allergic reactions or anaphylaxis. History of allergy to any of the component of Investigational product.
7. Any evidence of clinically significant acute illness or infection or fever within past 3 days of study participation.
8. Any evidence of clinically significant acute illness or infection or fever within past 3 days of vaccination. -Oral Temperature should not be = 37.8°C (100°F) on the day of vaccination.
9. Any major surgery within the past 90 days prior to vaccination.
10. Receipt of immunosuppressive therapy:
10.1) History of intake of anti-cancer chemotherapy or radiation therapy at any time in the past.
10.2) Systemic corticosteroid therapy (within the past 90 days prior to vaccination).
10.3) Received any other immunosuppressive therapy prior to study entry within a period that can interfere with study assessment in the clinical judgment of Investigator.
11. Have received blood products in the past 90 days prior to vaccination, including transfusions or immunoglobulin.
12. Use of anticoagulant medication in the past 90 days prior to vaccination.
13. Receipt of any vaccine in the past 4 weeks prior to study vaccination.
14. History of abusive usage of alcohol or drugs in the past 12 months that has caused medical problems.
15. Has participated in another clinical trial in the past 4 weeks prior to vaccination and planned participation in any other clinical trial during the present trial period.
16. Known tetanus or diphtheria disease/infection within 5 years of enrollment in the study.
17. Known or suspected acute respiratory illness at the time of study vaccination with active symptoms and signs including one or more of the following: rhinorrhea, new cough, pharyngitis or any other respiratory problems (e.g. asthma, wheezing, shortness of breath).
18. Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures or evidence of any other evolving neurological signs and symptoms.
19. Vaccinated with any diphtheria or tetanus containing vaccine within 5 years before inclusion.
20. History of recent contact with any confirmed case of COVID-19 or having tested positive for COVID-19 for less than a month.
21. Any other condition that might put in risk the safety/rights of a potential participant or hurdle his/her compliance with this protocol in investigator’s opinion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Proportion (Number and percentage) of subjects achieving seroprotection levels of anti-diphtheria and anti-tetanus antibodies in both test and comparator groups). <br/ ><br>2. Two sided 95% Cis for the difference in proportions of subjects achieving seroprotection rates of anti-Tetanus and anti-Diphtheria antibody titer. <br/ ><br>Timepoint: Day 28 post vaccination
- Secondary Outcome Measures
Name Time Method 1. Comparison of the geometric mean titer (GMT) and geometric mean titer ratio (GMR) of antibodies against diphtheria and tetanus toxoids between subjects who received the study vaccine and the comparator vaccine. <br/ ><br>2. Two fold and four fold rise in anti-Tetanus and anti-Diphtheria antibody titers. <br/ ><br>3. Incidence of solicited local and systemic reactions for 30 minutes post immunization and for the next 7 days <br/ ><br>4. Unsolicited AEs will be recorded 28 days post vaccination. <br/ ><br>5. SAEs will be recorded during the entire study period.Timepoint: Day 28 post vaccination